Senior Project Manager - Clinical Systems IRT/IVRS (JP5839)
Thousand Oaks, CA. or South San Francisco, CA., or Remote
CDM Global Systems ETO
1+ years (likely extensions and possible conversion to permanent)
3Key Consulting Inc. is looking for an Senior Project Manager with Clinical System
experience specifically in IRT/IVRS/RTSM/IXRS, for a global, CA-based, bio-pharmaceutical company.
The Manager, Clinical Systems ETO will work with cross-functional teams responsible for executing Amgen clinical trials, as well as, Interactive Response Technology (IRT) suppliers and Project Managers to support the design, implementation and maintenance of outsourced IRT systems. The role provides technical requirements consultation and project management oversight to ensure that the IRT designed for the study adheres to the study’s protocol, industry regulations / best practices, and Amgen policies, procedures and guidelines.
Top Must-Have Skills:
- 2-3 years of experience specifically in IRT/IVRS/RTSM/IXRS - either at a vendor, biotech or Pharma company.
- Must have been part of a build or project managed the build. This is an important skill set that the managers do not have time to train on, so candidate’s must be very skilled in this area. Candidates without this skill set/experience will be not be considered.
- This person will most likely come from a background in Business Analysis, Clinical Supply, Project Management.
- Candidate must have clinical experience.
- Doctorate Degree OR;
- Master's Degree & 3 years of Clinical experience OR;
- Bachelor's Degree & 5 years of Clinical experience OR;
- Associate's degree & 10 years of Clinical experience OR;
- High school diploma/GED & 12 years of Clinical experience.
Day to Day Responsibilities
- Bachelor’s Degree in life science, computer science, engineering, business or related discipline.
- 4+ years of experience in clinical operations, clinical supply chain or clinical systems management.
- Experience implementing clinical systems, such as IRT and eCOA .
- Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution.
- Detail-oriented and able to manage many projects simultaneously.
- Excellent documentation and communication skills.
- Meeting management and facilitation skills.
- Vendor management experience.
- Excellent time management and organization skills in a timeline-driven environment.
- Sound problem resolution, judgment, and decision-making abilities.
- Work well in a team-based environment with minimal supervision
Employee Value Proposition:
- Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts.
- Design and oversee the development of study-specific IRT technical documents.
- Document issues and risks, and implement mitigation plans in partnership with study team and vendor PM.
- Identify and track study-related technical issues to resolution.
- Closely manage project-related timelines and associated activities
Chance to join fast paced dynamic team where the candidates will be challenged and have a direct positive impact on patient’s lives. Based on performance there is a possibility of FTE opportunities if available.
Phone interview followed by in-person.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.